BS ISO 23089-2:2021 - Implants for Surgery

Welcome to the comprehensive guide on the BS ISO 23089-2:2021 standard, a pivotal document in the realm of surgical implants. This standard is essential for professionals involved in the design, testing, and implementation of spinal intervertebral body fusion devices. Released on June 3, 2021, this document provides a detailed framework for the pre-clinical mechanical assessment of spinal implants, ensuring they meet the highest safety and performance standards.

Overview of BS ISO 23089-2:2021

The BS ISO 23089-2:2021 standard is a critical resource for anyone involved in the development and evaluation of spinal implants. It outlines specific requirements for the mechanical assessment of these devices, focusing on their performance in pre-clinical settings. This ensures that the implants are not only effective but also safe for use in surgical procedures.

Key Features

• Standard Number: BS ISO 23089-2:2021
• Pages: 14
• Release Date: June 3, 2021
• ISBN: 978 0 539 01737 3
• Status: Standard

Importance of Spinal Intervertebral Body Fusion Devices

Spinal intervertebral body fusion devices play a crucial role in modern spinal surgery. These devices are designed to provide stability and support to the spine, facilitating the fusion of vertebrae. The BS ISO 23089-2:2021 standard ensures that these devices undergo rigorous mechanical testing before they are approved for clinical use. This is vital for patient safety and the overall success of spinal surgeries.

Pre-Clinical Mechanical Assessment

The pre-clinical mechanical assessment outlined in this standard is designed to evaluate the performance of spinal implants under various conditions. This includes testing for durability, strength, and resistance to wear and tear. By adhering to these guidelines, manufacturers can ensure that their products meet the necessary safety and performance criteria.

Why Choose BS ISO 23089-2:2021?

Choosing the BS ISO 23089-2:2021 standard is a testament to a commitment to quality and safety in the field of spinal surgery. This standard provides a comprehensive framework for the evaluation of spinal implants, ensuring they are fit for purpose and capable of delivering the desired clinical outcomes.

Benefits of Compliance

• Enhanced Safety: Ensures that spinal implants are safe for use in surgical procedures.
• Improved Performance: Guarantees that devices meet high-performance standards.
• Regulatory Approval: Facilitates compliance with international regulatory requirements.
• Market Confidence: Builds trust with healthcare providers and patients.

Conclusion

The BS ISO 23089-2:2021 standard is an indispensable resource for professionals in the field of spinal surgery. By providing a detailed framework for the pre-clinical mechanical assessment of spinal implants, it ensures that these devices are safe, effective, and reliable. Whether you are a manufacturer, healthcare provider, or researcher, this standard is essential for ensuring the highest standards of patient care and safety.

Invest in the BS ISO 23089-2:2021 standard today and take a significant step towards excellence in spinal surgery.

BS ISO 23089-2:2021

This standard BS ISO 23089-2:2021 Implants for surgery. Pre-clinical mechanical assessment of spinal implants and particular requirements is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures.

This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.